Summary: To evaluate the efficacy and safety of risedronate sodium in treatment of postmenopausal osteoporosis, one-year randomized, double blind clinical trial was performed among 54 women with postmenopausal osteop...Summary: To evaluate the efficacy and safety of risedronate sodium in treatment of postmenopausal osteoporosis, one-year randomized, double blind clinical trial was performed among 54 women with postmenopausal osteoporosis. The changes were compared in bone mineral density (BMD), bone metabolism markers and adverse events after 12 months oral administration of risedronate sodium. BMD was measured by dual energy X-ray absorptionmetry (DEXA) and bone turnover marker was detected. The results showed that there was a significant increase in BMD of the lumbar spine (3.29 %±41.18 %, 4.51%±1.64 % respectively) after 6 and 12 months in the risedronate treatment group versus placebo control group (-0.62 %±0.24 %, 0.48 %±0. 18 % respectively). Bone turnover was decreased to a stable nadir over 6 and 12 months for resorption markers [N-Telopeptide (NTx), P〈0.05] and over 12 months for formation marker (ALP, P〈0.05; BGP, P〈0. 05). The safety profile of risedronate sodium was similar to that of placebo. There were no trends toward increased frequency of any adverse experience except for gastrointestinal symptoms (7.1%), rash (7.1%) and hematuria (3.6 %), which were usually mild, transient, and resolved with continued treatment. It was concluded that risedronate was an efficacious and safe drug in treatment of postmenopausal osteoporosis.展开更多
AIM: To examine the effects of treatment with risedronate for 1 year on speed of sound(SOS) of the calcaneus and bone turnover markers in postmenopausal women with osteoporosis. METHODS: Thirty-eight postmenopausal wo...AIM: To examine the effects of treatment with risedronate for 1 year on speed of sound(SOS) of the calcaneus and bone turnover markers in postmenopausal women with osteoporosis. METHODS: Thirty-eight postmenopausal women with osteoporosis who had been treated with risedronate for > 1 year were enrolled in the study. The SOS and bone turnover markers were monitored during treatment with risedronate for 1 year. RESULTS: The urinary levels of cross-linked N-terminal telopeptides of type Ⅰ collagen and serum levels of alkaline phosphatase were significantly decreased at 3 mo(-34.7%) and 12 mo(-21.2%), respectively, compared with the baseline values. The SOS increased modestly, but significantly by 0.65% at 12 mo compared with the baseline value. Treatment with risedronate elicited an increase in the SOS of the calcaneus exceeding the coefficient of variation in vivo(0.27%). CONCLUSION: The present study confirmed that risedronate suppressed bone turnover and elicited a clinically significant increase in the SOS of the calcaneus in postmenopausal women with osteoporosis.展开更多
Introduction: The primary objective of this study was to determine whether risedronate sodium (Actonel?) therapy, in conjunction with conventional non-surgical periodontal treatment, reduces the rate of alveolar bone ...Introduction: The primary objective of this study was to determine whether risedronate sodium (Actonel?) therapy, in conjunction with conventional non-surgical periodontal treatment, reduces the rate of alveolar bone loss. Secondary aims were to compare the incidence of patient dropouts in the risedronate and placebo groups, and to document adverse events. Methods: This double-blind randomized placebo-controlled trial was conducted in 125 patients with moderate to severe periodontitis. At baseline, three, and nine months, standardized vertical bite-wing radiographs were taken and used to measure bone loss. Clinical periodontal examinations were taken at three-month intervals to assess whether or not the patient was experiencing rapid periodontal breakdown, in which case suitable treatment could be planned and delivered. Patients received scaling and root planing at baseline and periodontal maintenance at three-month intervals thereafter. At three months, subjects were randomly assigned to risedronate (35 mg/week by mouth) or placebo in blocks based on the severity of periodontitis (moderate, mean bone loss 2 -4 mm;or severe, mean bone loss >4 mm);smoking;and diabetes. Interval bone loss in millimeters was measured from the radiographs, and analysis of variance (ANOVA) was used to test for differences in bone loss between test and placebo groups. Results: Over the nine-month study duration, the test group exhibited a significantly greater increase in bone height (0.31 ±0.09 mmgain test, 0.08 ±0.09 mmgain placebo, F = 4.94, p < 0.04). There were significantly fewer dropouts in the risedronate treated group (4.8%) than in the placebo treated group (17.5%;p < 0.04, Fisher Exact Test). No serious adverse events or cases of osteonecrosis of the jaw (ONJ) were observed. Conclusions: Periodontitis subjects treated with risedronate had significantly more bone gain compared to placebo treated subjects. Significantly more subjects from the placebo group dropped out, suggesting the possibility of a patient-noticeable effect. There was no indication of ONJ.展开更多
Nanomechanical heterogeneity is expected to have an effect on elasticity, injury and bone remodelling. In normal bone, we have two types of cells (osteoclasts and osteoblasts) working together to maintain existing bon...Nanomechanical heterogeneity is expected to have an effect on elasticity, injury and bone remodelling. In normal bone, we have two types of cells (osteoclasts and osteoblasts) working together to maintain existing bone. Bone cancers can produce factors that make the osteoclasts work harder. This means that more bone is destroyed than rebuilt, and leads to weakening of the affected bone. We report here the first demonstration of the nanoscale stiffness distribution in bone metastases before and after treatment of animals with the bisphosphonate Risedronate, a drug which is currently used for the treatment of bone metastases in patients with advanced cancers. The strategy used here is applicable to a wide class of biological tissues and may serve as a new reflection for biologically inspired scaffolds technologies.展开更多
文摘Summary: To evaluate the efficacy and safety of risedronate sodium in treatment of postmenopausal osteoporosis, one-year randomized, double blind clinical trial was performed among 54 women with postmenopausal osteoporosis. The changes were compared in bone mineral density (BMD), bone metabolism markers and adverse events after 12 months oral administration of risedronate sodium. BMD was measured by dual energy X-ray absorptionmetry (DEXA) and bone turnover marker was detected. The results showed that there was a significant increase in BMD of the lumbar spine (3.29 %±41.18 %, 4.51%±1.64 % respectively) after 6 and 12 months in the risedronate treatment group versus placebo control group (-0.62 %±0.24 %, 0.48 %±0. 18 % respectively). Bone turnover was decreased to a stable nadir over 6 and 12 months for resorption markers [N-Telopeptide (NTx), P〈0.05] and over 12 months for formation marker (ALP, P〈0.05; BGP, P〈0. 05). The safety profile of risedronate sodium was similar to that of placebo. There were no trends toward increased frequency of any adverse experience except for gastrointestinal symptoms (7.1%), rash (7.1%) and hematuria (3.6 %), which were usually mild, transient, and resolved with continued treatment. It was concluded that risedronate was an efficacious and safe drug in treatment of postmenopausal osteoporosis.
文摘AIM: To examine the effects of treatment with risedronate for 1 year on speed of sound(SOS) of the calcaneus and bone turnover markers in postmenopausal women with osteoporosis. METHODS: Thirty-eight postmenopausal women with osteoporosis who had been treated with risedronate for > 1 year were enrolled in the study. The SOS and bone turnover markers were monitored during treatment with risedronate for 1 year. RESULTS: The urinary levels of cross-linked N-terminal telopeptides of type Ⅰ collagen and serum levels of alkaline phosphatase were significantly decreased at 3 mo(-34.7%) and 12 mo(-21.2%), respectively, compared with the baseline values. The SOS increased modestly, but significantly by 0.65% at 12 mo compared with the baseline value. Treatment with risedronate elicited an increase in the SOS of the calcaneus exceeding the coefficient of variation in vivo(0.27%). CONCLUSION: The present study confirmed that risedronate suppressed bone turnover and elicited a clinically significant increase in the SOS of the calcaneus in postmenopausal women with osteoporosis.
文摘Introduction: The primary objective of this study was to determine whether risedronate sodium (Actonel?) therapy, in conjunction with conventional non-surgical periodontal treatment, reduces the rate of alveolar bone loss. Secondary aims were to compare the incidence of patient dropouts in the risedronate and placebo groups, and to document adverse events. Methods: This double-blind randomized placebo-controlled trial was conducted in 125 patients with moderate to severe periodontitis. At baseline, three, and nine months, standardized vertical bite-wing radiographs were taken and used to measure bone loss. Clinical periodontal examinations were taken at three-month intervals to assess whether or not the patient was experiencing rapid periodontal breakdown, in which case suitable treatment could be planned and delivered. Patients received scaling and root planing at baseline and periodontal maintenance at three-month intervals thereafter. At three months, subjects were randomly assigned to risedronate (35 mg/week by mouth) or placebo in blocks based on the severity of periodontitis (moderate, mean bone loss 2 -4 mm;or severe, mean bone loss >4 mm);smoking;and diabetes. Interval bone loss in millimeters was measured from the radiographs, and analysis of variance (ANOVA) was used to test for differences in bone loss between test and placebo groups. Results: Over the nine-month study duration, the test group exhibited a significantly greater increase in bone height (0.31 ±0.09 mmgain test, 0.08 ±0.09 mmgain placebo, F = 4.94, p < 0.04). There were significantly fewer dropouts in the risedronate treated group (4.8%) than in the placebo treated group (17.5%;p < 0.04, Fisher Exact Test). No serious adverse events or cases of osteonecrosis of the jaw (ONJ) were observed. Conclusions: Periodontitis subjects treated with risedronate had significantly more bone gain compared to placebo treated subjects. Significantly more subjects from the placebo group dropped out, suggesting the possibility of a patient-noticeable effect. There was no indication of ONJ.
基金This work was supported by the NanoOSCAR ANR project from the“Agence Natiionale la Recherche”,the“Fondation Avenir”,the“Ligue contre le Cancer du Haut-Rhin,Région Alsace”and“Cancéropôle du Grand Est”.
文摘Nanomechanical heterogeneity is expected to have an effect on elasticity, injury and bone remodelling. In normal bone, we have two types of cells (osteoclasts and osteoblasts) working together to maintain existing bone. Bone cancers can produce factors that make the osteoclasts work harder. This means that more bone is destroyed than rebuilt, and leads to weakening of the affected bone. We report here the first demonstration of the nanoscale stiffness distribution in bone metastases before and after treatment of animals with the bisphosphonate Risedronate, a drug which is currently used for the treatment of bone metastases in patients with advanced cancers. The strategy used here is applicable to a wide class of biological tissues and may serve as a new reflection for biologically inspired scaffolds technologies.